Description

Flibanserin,sold under the trade name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD).The medication increases the number of satisfying sexual events per month by about one half to one over placebo from a starting point of about two to three.

Flibanserin is used for hypoactive sexual desire disorder among women. Those receiving flibanserin report that the average number of times they had “satisfying sexual events” rose from 2.8 to 4.5 times a month. However, women receiving placebo reported also an increase of “satisfying sexual events” from 2.7 to 3.7 times a month. Evaluation of the overall improvement of their condition and whether the benefit was meaningful to the women, showed a significantly higher rate of a meaningful benefit in the flibanserin-treated people versus the placebo group.The onset of the flibanserin effect was seen from the first timepoint measured after 4 weeks of treatment and maintained throughout the treatment period.

The effectiveness of flibanserin was evaluated in three phase 3 clinical trials. Each of the three trials had two co-primary endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire. Each of the 3 trials also had a secondary endpoint that measured distress related to sexual desire.

All three trials showed that flibanserin produced a statistically significant increase in the number of SSEs and reduced distress related to sexual desire.

The first two trials used an electronic diary to measure sexual desire, and did not find a statistically significant increase relative to women treated with a placebo. These two trials also measured sexual desire using the Female Sexual Function index (FSFI) as a secondary endpoint, and a statistically significant increase was observed using this latter measure. The FSFI was used as the co-primary endpoint for sexual desire in the third trial, and again showed a statistically significant increase.